Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)

Phase 4

Terminated

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Placebo; Drug: Acthar Gel

• Registration Number: NCT03126760
• Lead Sponsor: Mallinckrodt ARD LLC

Brief Summary

This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Study Start: 2017-05-22
• Primary Completion: 2020-07-14
• Study Completion: 2020-07-14
• Results First Submitted: 2021-05-10
• Results First Submitted QC: 2021-05-10
• Status Verified: 2021-06
• Results First Posted: 2021-06-03
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)
• Had a relapse with onset ≤42 days prior to the Baseline Visit
• Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom
• Had failed to obtain improvement of at least 1 point in one or more functions on the Function Systems Score (FSS) 14 days following their first dose of high dose corticosteroids
• Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receive Placebo under the skin once a day for 14 consecutive days
Acthar Gel	Acthar Gel	Participants receive Acthar Gel under the skin once a day for 14 consecutive days

Primary Outcome Measures

Name	Time	Method
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42	Baseline, Day 42	The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.

Trial Locations

Locations (22)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Advanced Neurosciences Research LLC; 🇺🇸 Fort Collins, Colorado, United States

University of South Florida; 🇺🇸 Bradenton, Florida, United States

Neurology Associates, P. A.; 🇺🇸 Maitland, Florida, United States

University of Miami - Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Tallahassee Neurological Clinic, PA; 🇺🇸 Tallahassee, Florida, United States

Multiple Sclerosis Center of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Meridian Clinical Research LLC; 🇺🇸 Savannah, Georgia, United States

Consultants in Neurology LTD; 🇺🇸 Northbrook, Illinois, United States

OSF Healthcare System Saint Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

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